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Operationalizing GMP AI for Impact at Scale
Join us for a private executive session focused on real implementations, GxP validation in production, and how manufacturing leaders are overcoming the AI scalability challenge on the shop floor.
The AI pilot worked. Now it's sitting in a spreadsheet, with no roadmap to production.
Data architecture
AI runs on data, not slide decks. Before Recordati delivered a 1.5% yield increase, they connected SCADA, MES, LIMS, and MBRs into a single layer inside a running plant. That foundation is the bridge from pilot to production.
Validation challenges
QA sign-off on ML in GMP demands a validation framework most teams don't have. Operationalizing AI means documenting model updates, managing drift, and holding an audit trail that survives inspection.
Multi-model governance
No two plants, lines, or products are alike, so every model is custom. Deploying many models and governing them all under GMP is a core barrier to operationalizing AI. It takes operational infrastructure designed for governance.
ROI stays invisible
Operations sees the value; finance needs it in their language. That translation gap is a consistent blocker. The fix is specific, auditable numbers tied to production outcomes, like a 4% yield gain worth more than $30M.
Why you should attend the GMP AI Summit
» REAL CASEs: Grifols, fresenius kabi, recordati, AND MORE
Get an inside look at how real pharmas and CDMOs are deploying GxP-compliant AI to unify complex operational data and drive yield optimization across their global facilities.» proven AI Use Cases in pharma manufacturing
See exactly how industrial-grade AI is driving concrete ROI today in Deviation Reduction, Yield Optimization, Increased Capacity, and Faster Product Release.» rapid analytics prototyping session
Build a functional analytics dashboard in minutes using real production data and agentic AI tools. Answer real questions in real time.» A Framework for Proving ROI to Leadership
Learn how to prioritize AI use cases based on operational and financial impact, so you can make the internal business case with confidence based on your own data.» Direct Access to Peers Actually Doing This
A closed room of senior leaders from top biomanufacturing companies. Share strategies, validate your approach, and engage in structured, genuinely useful peer exchange without vendors pitching from a booth.
Agenda
07:45 am
Guest Reception & Registration08:00 am
Opening Remarks: GMP AI: Reality vs Hype08:30 am
Exploring Real-World Use Cases With P&L Impact09:30 am
Data Readiness For AI in Pharma Manufacturing10:10 am
Compliance & AI: Navigating the New Regulatory Landscape10:40 am
Fireside Chat: GMP & Data Integrity Validation11:30 am
Scaling AI: From Pilot Programs to Operationalization12:00 pm
Executive Lunch Break01:00 pm
Guided Tour of Sant Pau Modernist Complex02:00 pm
The World is Shifting: The Challenges Facing CDMOs02:30 pm
Hands-on Workshop: Build Dynamic Analytics Applications With Agentic AI03:30 pm
Digitalization is Not an Excuse04:45 pm
Open Discussion Forum: AI in GMP Manufacturing05:30 pm
Closing Remarks06:00 pm
Executive Networking Dinner
Who you’ll meet and network with
SVP QUALITY, Lonza
SVP QUALITY, Lonza
SVP QUALITY, Lonza
SVP QUALITY, Lonza
SVP QUALITY, Lonza
SVP QUALITY, Lonza
SVP QUALITY, Lonza
SVP QUALITY, Lonza
About your Hosts
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Register your interest
The Venue: Sant Pau Modernist Complex
Designed by Lluís Domènech i Montaner, Sant Pau Recinte Modernista is one of the most architecturally significant buildings in Barcelona, and the perfect location to bring together leaders who ultimately serve the patient. As part of the event, you will get to enjoy a private tour of this remarkable architectural landmark.
Barcelona · UNESCO World Heritage Site